Associate II, Reg CMC Strategy

About the Role

Functions as a CMC strategist for the development of CMC regulatory strategies, submissions, and compliance activities for commercial pharmaceutical products supporting HBU’s Business. Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post-approval activities. Primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities.

Key Responsibilities

• Prepares the CMC information for submission to global regulatory agencies.
• Generates and drives CMC strategies.
• Assesses risks and develops contingency/mitigation plans.
• Acts as the global CMC representative within cross-functional project teams.
• Interprets regulations and guidelines and assesses global implications for strategic CMC decisions.
• Represents CMC during interactions with internal partners either directly or in conjunction with Team Lead.
• Resolves issues and manages regulatory risks within project teams.
• Makes decisions to resolve moderate problems in standard situations as per guidance and policies.
• Ensures compliance to Pfizer's training activities.
• Participates in cross-disciplinary forums and learning opportunities.
• Demonstrates and models adherence to all Pfizer behaviors and values.
• Embraces and complies with Principles of Integrity.
• Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, Rosetta, etc., as appropriate.

Requirements & Tech Stack

• Work is periodically reviewed by Team Lead.
• Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, Rosetta, etc.
• Work Location Assignment: Hybrid

Qualifications

• Regulatory Affairs